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Original Article

A practical approach to designing operating instructions for medical products in late or post-design phases

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Pages 238-244 | Published online: 09 Jul 2009

References

  • FDA. Labeling: Part 801 of Title 21 of the Code of Federal Regulations (21 CFR 801). Food and Drug Administration, Rockville, MD 2007
  • TSO. The Medical Devices Regulations 2002. The Stationery Office, NorwichUK 2002
  • Everard M. L. Playing the game: designing inhalers for pediatric use. Respiratory Drug Delivery Europe 2007; 1: 71–78
  • Backinger C. L., Kingsley P. A. Write It Right: Recommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care. Food and Drug Administration, Rockville, MD 1993
  • MRHA. Managing Medical Devices: Guidance for Healthcare and Social Services Organisations, DB 2006(05). Department of Health, London 2006
  • FDA. Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers. Food and Drug Administration, Rockville, MD 2001
  • FDA. Human Factors Principles for Medical Device Labeling. Food and Drug Administration, Rockville, MD 1993
  • GSK. Instructions for Using ADVAIR DISKUS. GlaxoSmithKline, USA 2008, Available at http://us.gsk.com/products/assets/us_advair.pdf (accessed 3 February 2009)
  • Gupta S. P. Design and delivery of medical devices for home-use: drivers and challenges. 2007, PhD thesis, University of Cambridge, Cambridge, UK

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